Epidural Bupivacaine for Labor Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests the amount of bupivacaine, a pain relief medicine, needed to help women in labor feel comfortable. It compares two methods of administering the medicine through an epidural: the dural puncture epidural technique and the conventional epidural technique. Both methods aim to effectively ease labor pain. Women who are at full-term pregnancy, have no major health issues, and seek an epidural for labor pain relief might be suitable candidates. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to further understand its benefits for more patients.
What is the safety track record for Bupivacaine Hydrochloride?
Research has shown that bupivacaine, a medication used to relieve pain during labor, is generally safe. Studies have found that administering bupivacaine through a method called dural puncture epidural (DPE) provides effective pain relief with fewer side effects than some other methods. Common minor side effects might include a drop in blood pressure, but serious problems are rare. Overall, bupivacaine is well-tolerated in low doses, making it a reliable choice for women in labor.12345
Why are researchers enthusiastic about this study treatment?
Unlike traditional epidural techniques for labor pain, which often rely on standard dosing protocols, this trial explores two techniques: the Dural Puncture Epidural (DPE) and the Conventional Epidural Technique (EPL) using bupivacaine. Researchers are excited about the DPE technique because it allows for a more tailored approach to pain management. By adjusting doses based on each patient's response, it could lead to more effective pain relief with potentially lower medication doses. This personalized dosing strategy could represent a significant advancement in labor pain management, providing more comfort to mothers during childbirth.
What is the effectiveness track record for Bupivacaine in managing labor pain?
Research has shown that bupivacaine effectively manages labor pain. In this trial, participants will receive either the dural puncture epidural (DPE) technique or the conventional epidural technique. Studies have found that DPE provides faster and better pain relief than traditional epidurals, being 50% more effective at easing pain. This method also tends to cause fewer side effects, such as low blood pressure, compared to other techniques. Overall, using bupivacaine with DPE offers a reliable option for managing labor pain.14678
Are You a Good Fit for This Trial?
This trial is for women in labor at term (37-42 weeks) with a single baby positioned head down, who want epidural pain relief and have moderate to severe pain. They should be less than 5 cm dilated and without major health issues or conditions that increase the risk of cesarean delivery.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a lidocaine test dose followed by bupivacaine via the epidural technique to achieve effective labor analgesia
Follow-up
Participants are monitored for safety and effectiveness after receiving the epidural analgesia
What Are the Treatments Tested in This Trial?
Interventions
- Bupivacaine Hydrochloride
Trial Overview
The study aims to find the right dose of bupivacaine, an anesthetic drug given through the back into the epidural space, which can effectively reduce labor pain in 90% of patients after they've had a lidocaine test dose.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Laboring women receiving the Dural Puncture Epidural (DPE) Technique, after a lidocaine "test dose", with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the DPE group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Laboring women receiving the Conventional Epidural Technique (EPL), after receiving a lidocaine "test dose" with dose of Bupivacaine 0.25% diluted to 20 mL with isotonic sterile 0.9% saline. The first subject in the EPL group will receive an initial dose of bupivacaine 25 mg, with an endpoint being the achievement of an NRS \< 3 at 30 min. Subsequent patients are administered bupivacaine doses determined by the response of the previous subject, as per the biased coin method. The subsequent up and down interval doses are bupivacaine 2.5 mg (1 mL) increments, with an anticipated dose range from 20 mg to 40 mg.
Bupivacaine Hydrochloride is already approved in United States, European Union for the following indications:
- Local anesthesia
- Postoperative pain
- Cesarean section
- Epidural anesthesia
- Caudal blocks
- Sympathetic nerve block
- Peripheral nerve block
- Local anesthesia
- Regional anesthesia
- Pain relief
Find a Clinic Near You
Who Is Running the Clinical Trial?
Brigham and Women's Hospital
Lead Sponsor
Citations
Effects of different bupivacaine concentrations with dural ...
Dural puncture epidural (DPE) provides a faster, higher-quality block than CE and causes fewer adverse effects, such as hypotension, maternal ...
Obstetrics Epidural analgesia versus dural puncture ...
The DPE technique was found to be 50% more effective in providing adequate pain relief compared with traditional epidural analgesia.
3.
journals.lww.com
journals.lww.com/md-journal/fulltext/2024/11080/effect_of_dural_puncture_epidural_technique.6.aspxEffect of dural puncture epidural technique combined with...
Studies have shown that DPE is a safe and effective technique for labor analgesia. It provides faster and more adequate analgesia than EP.
Bupivacaine for Labor Pain
Studies have shown that DPE is a safe and effective technique for labor analgesia. It provides faster and more adequate analgesia than EP. 7. withpower.com.
Epidural vs. Dural Puncture Epidural in Labor Analgesia
Outcomes evaluated include total bupivacaine consumption, adequate analgesia success (NRS < 4), maternal hemodynamic changes, incidence of ...
Epidural analgesia versus dural puncture ...
This meta-analysis compared clinical outcomes between parturients receiving epidural analgesia vs DPE analgesia for labour pain. Methods.
Dural Puncture Epidural Analgesia Is Not Superior To ...
Dural puncture with a 27-gauge Whitacre needle as part of a combined spinal-epidural technique does not improve labor epidural catheter function.
DURAL PUNCTURE EPIDURAL
Dural puncture epidural technique improves labor analgesia quality with fewer side effects compared with epidural and combined spinal epidural techniques:
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